March Madness came early for CMS, with more than 7,600 public comments received on their Medicare Part D proposed rules and technical changes for 2015. Less than 72 hours after that docket closed, CMS unfurled their white flag via a March 10 letter to Congress, retracting certain highly-contentious provisions, as previewed in recent posts on Health Affairs Blog by Jack Hoadley and Ian Spatz. However, CMS’ hasty retreat should not signal a relaxed advocacy in the coming weeks. Like NCAA basketball’s March Madness, much remains in play, especially given Part D’s programmatic (and patient-level) complexity.

For example, in their March 14 report to Congress, the Medicare Payment Advisory Commission (MedPAC) expressed concern “about the quality of pharmaceutical care received by beneficiaries with multiple medications.” MedPAC notes that Part D enrollees’ medical problems may be “caused or exacerbated by their heavy use of medications (polypharmacy), and they are at increased risk of adverse drug events, drug-drug interactions, and use of inappropriate medications.”

To help alleviate such potential risk, prescient policymakers required Part D plan sponsors to implement medication therapy management (MTM) programs, something that I examined closely during my tenure at AARP. Within Part D, MTM’s experience to date represents a cautionary tale of missed opportunities to bring clinicians, patients, and drug plans together to achieve the Triple Aim. This commentary reviews several challenges, and identifies new positive cues to better integrate systematic, patient-centered medication management across all of Medicare.

If You Build It (MTM), They Will Come – Not Yet!

Hailed in 2006 by then-CMS Administrator Mark McClellan as a “win-win” proposition for plans, pharmacists, and patients, MTM’s goal is to help patients avoid drug-related problems, and achieve optimal clinical benefits. Provided to eligible enrollees for free, MTM was intended to be an important value-add to Part D’s quality ingredients. But in Part D’s ninth year, CMS’ self-imposed March Madness means the agency must quickly reconcile a perplexing panorama for 2015: (1) broad expansion of MTM, per the proposed rules, and (2) a relatively status quo approach in their advance “call letter.” The comment period for both closed on March 7.

CMS proposed dramatically lowering MTM’s barriers to entry, an approach supported by many national pharmacy organizations in their joint letter to CMS. Each year, CMS adjusts MTM eligibility criteria: (a) the annual drug-cost threshold – $4,000 in 2006, $3,000 by 2010; and possibly plunging to $620 in 2015; (b) the number of covered drugs (ranging from two to eight); and (c) the type and number of chronic diseases (two or three). Plans have leeway on the latter two criteria.

Dropping the drug-cost threshold to $3,000 led CMS to predict that 25 percent of Part D enrollees would be MTM-eligible. However, program eligibility rates have been flat-lined since 2007, despite rapid enrollment increases (37 million beneficiaries in drug plans in 2014), and were less than 8 percent in 2011. CMS estimates that 2.5 million beneficiaries are eligible for MTM services today; reducing the threshold to $620 would permit 55 percent of Part D enrollees to be eligible – a seven-fold increase. In their February 28 letter to CMS, MedPAC questioned whether such new criteria “are the most effective way” to achieve MTM’s intended goal.

Unsupported Infrastructure Yields “Simplistic Strategies”

CMS is not ignorant of Part D MTM’s challenging evolution. The proposed rules noted concern about “simplistic generalized strategies” that represent a default for delivering MTM services. Similarly, the advance call letter reminded plan sponsors to not restrict MTM eligibility criteria so as “to limit the number and percent of beneficiaries who qualify.” The less-than-robust implementation, however, is likely related to Part D’s unsupported infrastructure – which neither regulatory offering addressed.

Without a budget line-item allocated to MTM, program costs must be built into drug plans’ prospective bids submitted to CMS each June. Indeed, the draft call letter invited sponsors to offer MTM services to “an expanded population” who do not otherwise meet eligibility criteria, with CMS advising plans to “incorporate these additional costs…. in their bids.”

Such an approach is not sustainable. Two-thirds of Part D enrollees select stand-alone Part D plans over Medicare Advantage drug plans; the former are at risk for drug costs only, and thus have little incentive to invest in often labor-intensive MTM programs that could help prevent drug-related events that may surface in Parts A and B – downstream events that may not materialize in the same calendar year as MTM services are provided. Consequently, some plans may avoid aggressively pursuing eligible enrollees to partake in any MTM, let alone outreach to non-eligibles who might benefit even more, per Bruce Stuart’s Health Affairs investigation last July.

Further, Part D MTM-eligible patients may overlook their drug plan’s letter inviting them for a comprehensive medication review (CMR): only 10 percent of MTM-eligible enrollees undergo a CMR, CMS notes. Their call letter said that in 2013, one-fourth of all CMR offers were untimely. That would include my mother’s: her CMR offer arrived five months after her brief emergency hospitalization, by which time her medication regimen had retreated to its minimal, pre-emergency antihypertensive regimen.

Among enrollees who receive a CMR, a plan’s call-center pharmacist, or another possibly remote MTM provider, is likely to conduct it. This contrasts with a 2013 Center for Medicare & Medicaid Innovation evaluation of Part D MTM that cited as a pillar of “effective” MTM programs, care coordination that utilized “trusted community relationships including networks of community pharmacists to recruit” MTM-eligible patients. Such successful programs also drew on “existing working relationships” between pharmacists and prescribers to make recommendations and discuss patients’ drug-related problems. (Generally, prescribers’ acceptance of therapy recommendations happens about half the time).

(Missed) Cues to Support Triple Aim Medication Management

CMS acknowledges implementation challenges, yet their MTM proposals appear to overlook transformation occurring elsewhere in Medicare: systematically connecting patient clinical data with team members, including prescribers and pharmacists; or sharing savings with plans, or perhaps even with beneficiaries, as an inducement to say “yes” to a comprehensive medication review. Like continuous quality improvement, comprehensive medication management services – of which MTM is a subset – can guide team-based, systematic interventions to optimize resources and patient outcomes across the care continuum.

Several promising cues of this more integrated approach include:

CMS’ request-for-information, one on ACOs’ evolution (comment period closed), and another on specialty payment models (comments due April 10). Both ask how accountability for drugs can be factored into payment – not just for the drug product, as Part D does, but payment for optimization of drug outcomes. About half of current ACO quality metrics involve chronic medication use and monitoring, so comprehensive medication management services would seem to be a natural fit, but they are not a slam dunk. A small survey of ACOs found that “critical gaps remain” before ACOs “can become fully accountable” for medication use. However, Marie Smith and colleagues discussed synergistic evolving-care-model opportunities for pharmacists in Health Affairs last November; and a promising preview of patient-centered medical homes, ACOs and medication management projects in North Dakota, Iowa, and Nebraska was published in February.

On Capitol Hill, Senator Ron Wyden’s (D-OR) “Better Care, Lower Cost Act” (S. 1932, H.R. 3890) would promote clinician collaborations – including pharmacists – to manage the full care continuum for Medicare beneficiaries with multiple chronic conditions. Other policy experts proposed that Medicare adopt advanced primary care practice as a new provider category, open to “all providers meeting requirements on eligibility, reporting, performance, and accountability.” This approach would “accelerate the deployment of care teams” – including those with pharmacists, whose lack of Medicare provider status may thwart a sustainable business model, at least in the community retail setting. Last year, California enacted a law to remedy that; federal action remains in flux, with H.R. 4190 introduced on March 11, 2014.

As part of the American Geriatrics Society’s expanded Choosing Wisely list, seven of ten recommendations address medication use, including this one: “Don’t prescribe a medication without conducting a drug regimen review.” In Part D MTM, such a review might not occur until months after prescriptions have been written. The AGS action reaffirms the value of utilizing this tool closer to the original prescribing decision, something that is more feasible in team-based, accountable practices.

As a first step, providing comprehensive medication management services through evolving care models and through medical benefits, instead of repeatedly forcing MTM’s unaligned hand in Part D, would enable us to enhance the value of Medicare’s prescription drug coverage in pursuit of the Triple Aim. Our real work begins after March Madness ends.

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As MTM/DSM services become more mainstream, it is important to note that direct payor billing is just one barrier to providing a greater level of care. Too many physicians still do not see the ultimate value in pharmacist provided services & recommendations. A successful MTM program for those organizations with the drive and the proper resources to implement should have the support of the patient, the plan, and the prescriber in order to truly make an impact on outcomes. Direct payor billing and higher reimbursement rates are always welcome for any business model, but until prescribers understand the clinical value that pharmacists provide, MTM will continue to have challenges to success.

You do not say so but your comment appears to be addressed to me rather than the author of the post. My comment — and I think the post — is strictly limited to Medicare and to the difference between going with fee for service Medicare, a standalone supplement, and a standalone drug plan with no coordinated care (which is what 65% of Medicare beneficiaries do–about half of them using Part D as the standalone drug plan) or going with a capitated coordinated-care health plan (which is what 35% of Medicare beneficiaries do–almost all of them using Part C). I was not thinking in terms of “younger healthier folks.” Ms. Rucker’s post is all about Part D (and, although she doesn’t seem to dig into it because she takes a budgetary view, Part C).

If a senior goes with Part C, in my experience, he or she does not need the insurance company or pharmacists getting into the middle of the coordinated care it offers through the mandatory PCP (actually this was the way the classic HMO I originally joined worked as well although the classic HMO is long gone into separate corporate entities). Given your description of the relationship you expect (your wording implies you are an MD) it sounds like the MD community should bifurcate just as the Medicare choices have bifurcated: MDs who want to specialize on “complicated cases” and MDs who want to coordinate care. Actually I guess that has already happened.

While I agree with your highlighting the strange and oversimplified phrasing in that quote, I think the overall point is being missed. Yes, it may be frustrating viewing drug coverage from a budgetary viewpoint, but it is a fact that by covering the old and/or disabled the government is taking a far greater burden than any private insurer is willing to take on without mitigating that cost with younger healthier folks.
Moving into MTM is one way to create a great value proposition by helping prevent adverse drug events that physicians have truly struggled with both the time burden and, ostensibly, quality outcomes. MTM is not an attempt to bypass physicians, but rather an attempt to bridge the gap of care created by “high risk” patients who see multiple physicians and are on multiple medications with often poor communication between providers. Pharmacists are the most competent health care provider to manage a patient’s medication regimen. Their training along this vein far exceeds that of physicians, they cost less, and there is multitude of research that supports that they produce higher quality outcomes for complex patients than those who otherwise don’t utilize their expertise.
I completely agree that these patients should have a PCP, but that is not a means to an end and most PCPs would agree. I utilize a pharmacist in dealing with complex medication therapies because they have the ability and time to do it right, and they relieve me in dealing with these complicated cases that I’m only given “20” minutes to work through. I say leave the diagnosing to us and medications for the pharmacists, and then we can collaborate on therapy, which in my experience leads to great outcomes and cost savings for the patients and the system.

The following odd wording in the middle of this article may actually be a symptom of the problem. The author says:

“Two-thirds of Part D enrollees select stand-alone Part D plans over Medicare Advantage drug plans; the former are at risk for drug costs only, and thus have little incentive to invest in often labor-intensive MTM programs that could help prevent drug-related events that may surface in Parts A and B – downstream events that may not materialize in the same calendar year as MTM services are provided. ”

I understand why it is worded that way but the wording takes a budgetary view of our drug coverage, not a market-related or clinical view. In fact 100% of Part D enrollees select Part D and 100% of public Part C Medicare Advantage health plan enrollees select Part C (having to take whatever drug plan is built in). In Part C, the doctor manages the therapy. There is no need for the druggist or the insurance company to get involved (although I think the insurer is supposed to somehow? At least I assume that is the reason behind the useless 8-page mailing every month).

I am guessing most people truly on D (as opposed to on D in budgetary terms but really on C) do not have a primary care physician. So instead of fixing the problem the right way (and getting them one, insisting they have on if they want the Medicare, or whatever) the government feels the need to create multiple new bureaucratic programs.

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